Drug-drug Interaction Study Between UIC201601 and UIC201602

NCT ID: NCT05190133

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-28
• Study Completion Date: 2016-08-17

Brief Summary

An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A

Group Type: EXPERIMENTAL

UIC201602 and co-administration of UIC201601 and UIC201602

Intervention Type: DRUG

• UIC201602 4 Cap/day for 14 days
• Wash out 21 days
• UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Treatment B

Group Type: EXPERIMENTAL

UIC201601 and co-administration of UIC201601 and UIC201602

Intervention Type: DRUG

• UIC201601 4 Tab/day for 7 days
• Wash out 14 days
• UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Interventions

UIC201602 and co-administration of UIC201601 and UIC201602

• UIC201602 4 Cap/day for 14 days
• Wash out 21 days
• UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Intervention Type: DRUG

UIC201601 and co-administration of UIC201601 and UIC201602

• UIC201601 4 Tab/day for 7 days
• Wash out 14 days
• UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
• Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
• Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
• Subjects able to read and understand a written informed consent, and willing to participate in the study.

Exclusion Criteria

• Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
• Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
• Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
• Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
• Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
• etc.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korea United Pharm. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janghee Hong, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Other Identifiers

KUP-UI018-101

Identifier Type: -

Identifier Source: org_study_id